PharmaNet Consulting personnel includes former senior-level staff in the FDA’s Office for Vaccine Research and Review (OVRR) and Office of Tissue, Cell / Gene Therapy (OTCGT). Available consulting services include assistance with: study design, regulatory strategy, Chemistry/Manufacturing Controls (CMC) issues, assessment of long-term risks, and interpreting actions and policies of worldwide regulatory agencies.
PharmaNet professionals available for consultation on this topic include:
Vice President, PharmaNet Consulting
Joyce Lea Frey-Vasconcells, PhD
Executive Director, PharmaNet Consulting
504 Carnegie Center, Princeton, NJ 08540